Global Lomitapide Pregnancy Exposure Registry | NCT02399839

Studies
Global Lomitapide Pregnancy Exposure Registry

NCT02399839

Sponsor

Amryt Pharma

Status

Terminated

Last Update Posted

Dec 16, 2022Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

lomitapide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The PER objective has been integrated into the LOWER protocol.

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2022Actual

Completion Date

Dec 2022Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Mar 23, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2022

Last Update Posted Date

Dec 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the outcomes of pregnancy in women treated with lomitapide.

Detailed Description

To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
lomitapide	Drug	As prescribed by Physician.		Juxtapid Lojuxta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy	To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.	2 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.

Exclusion Criteria:

Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant Females

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sallyann O'Brien	Amryt Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Universität München		München	Bavaria	80336	Germany

Intervention Browse Module

MeSH Terms

ID	Term
C473731	BMS201038

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided